In this slide deck we look at:
- Why there is a need to move from the Medical Devices Directive, first introduced in 1993 to the new medical devices regulations.
- What are the most notable changes contained in the MDR?
- We look at the increased role of clinical data in the medical device regulations. The slide deck looks at issues regarding clinical evaluation reports.
- And finally, we look at the widening of the definition of what constitutes a medical device. The MDR brings in products that have previously been regarded as aesthetic and cosmetic products.